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CTRI Number  CTRI/2024/04/066114 [Registered on: 23/04/2024] Trial Registered Prospectively
Last Modified On: 22/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessment of thyroid dysfunction in heart failure patients 
Scientific Title of Study   Assessment of thyroid dysfunction in patients with heart failure: A cross-sectional observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anand Loya 
Designation  MD General Medicine Resident 
Affiliation  D Y Patil School of Medicine 
Address  3rd floor,General Medicine Department,D Y Patil School of Medicine, Nerul, Navi Mumbai
Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India 
Phone  8805718877  
Fax    
Email  dr.anandloya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arundhati Barua 
Designation  Professor 
Affiliation  D Y Patil School of Medicine 
Address  3rd floor,General Medicine Department,D Y Patil School of Medicine, Nerul, Navi Mumbai
Sector 5,Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India 
Phone  9819192212  
Fax    
Email  arundhatibb@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anand Loya 
Designation  MD General Medicine Resident 
Affiliation  D Y Patil School of Medicine 
Address  3rd floor,General Medicine Department,D Y Patil School of Medicine, Nerul, Navi Mumbai
Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India 
Phone  8805718877  
Fax    
Email  dr.anandloya@gmail.com  
 
Source of Monetary or Material Support  
D Y Patil Hospital,Sector 5,Nerul, Navi Mumbai. 400706 
 
Primary Sponsor  
Name  D Y Patil School of Medicine 
Address  Sector 5,Nerul,Navi Mumbai. 400706 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anand Loya  D Y Patil Hospital  Department of General Medicine, 3rd floor, Hospital building
Thane
MAHARASHTRA 		 8805718877

dr.anandloya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IECBH of D Y Patil Medical College and Hospital, Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I509||Heart failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients giving consent
Patient with Heart Failure 
 
ExclusionCriteria 
Details  Patients with congenital Heart disease 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of thyroid dysfunction in patients with heart failure
Correlation and association with Thyroid and heart failure 		 Day 1 of admission 
 
Secondary Outcome  
Outcome  TimePoints 
If correlation achieved prevalence would be seen
Screening patients for thyroid profile 		 Day 1 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Ask via email on dr.anandloya@gmail.com

  6. For how long will this data be available start date provided 29-02-2024 and end date provided 31-01-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Heart Failure is growing concern, finding the cause and timely treatment is of due importance. Many risk factors have been found although cause is multifactorial. 
This study would help in finding the prevalence of thyroid disorder and also association with Heart Failure could be made.
Heart failure may occur in patients with overt hypothyroidism in elderly and patients with sub-clinical hypothyroidism with TSH more than 10 due to effect of bradycardia,impaired systolic function,impaired left ventricular diastolic filling, increase systemic vascular resistance , diastolic hypertension , increased arterial stiffness and endothelial dysfunction.
 
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